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📦Notice of Priority Mail Service Changes by Postal Service in 2025

The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.

🚧Florida Gas Transmission Regulatory Notice for New Project 2024

✈️FAA Proposes Airspace Modification for Battle Mountain Airport

This action proposes to modify the Class E airspace area designated as surface area, establish a Class E airspace area designated as an extension to a Class D or Class E surface area, modify Class E airspace extending upward from 700 feet above the surface of the earth, and remove Class E airspace extending upward from 1,200 feet above the surface at Battle Mountain Airport, Battle Mountain, NV. Additionally, this action proposes administrative amendments to update the airport's existing Class E airspace legal descriptions. These actions would support the safety and management of instrument flight rules (IFR) operations at the airport.

📦USPS Notice on Priority Mail Negotiated Service Agreement

The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.

⚖️USITC Notice of Antidumping Investigation on Slag Pots from China

The Commission hereby gives notice of the institution of investigations and commencement of preliminary phase antidumping and countervailing duty investigation Nos. 701-TA-753 and 731-TA-1731 (Preliminary) pursuant to the Tariff Act of 1930 ("the Act") to determine whether there is a reasonable indication that an industry in the United States is materially injured or threatened with material injury, or the establishment of an industry in the United States is materially retarded, by reason of imports of slag pots from China, provided for in subheading 7309.00.00 of the Harmonized Tariff Schedule of the United States, that are alleged to be sold in the United States at less than fair value and alleged to be subsidized by the Government of China. Unless the Department of Commerce ("Commerce") extends the time for initiation, the Commission must reach a preliminary determination in antidumping and countervailing duty investigations in 45 days, or in this case by February 14, 2025. The Commission's views must be transmitted to Commerce within five business days thereafter, or by February 24, 2025.

⚖️FDA Guidance on Sex-Specific Data in Medical Device Studies

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Evaluation of Sex- Specific and Gender-Specific Data in Medical Device Clinical Studies." This document provides guidance on the study and evaluation of sex- and/or gender-specific data in clinical investigations or research involving one or more subjects to determine the safety or effectiveness of a device. The purpose of this guidance is to encourage science- driven consideration of sex and/or gender, as appropriate for both the scientific question being addressed and the intended use of the device, when designing medical device clinical studies and reporting data from such studies in accordance with legal requirements. This draft guidance is not final nor is it for implementation at this time.

🌊FEMA's Technical Mapping Advisory Council Meeting Notice

The Federal Emergency Management Agency (FEMA) Technical Mapping Advisory Council (TMAC) will hold a virtual meeting on Friday, January 24, 2025. The meeting will be open to the public via a Microsoft Teams Video Communications link.

🩺FDA Draft Guidance on Reducing Disease Transmission Risks in HCT/Ps

The Food and Drug Administration (FDA or Agency) is announcing the availability of three specific draft guidances for industry entitled "Recommendations to Reduce the Risk of Transmission of Hepatitis B Virus (HBV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps);" "Recommendations to Reduce the Risk of Transmission of Hepatitis C Virus (HCV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps);" and "Recommendations to Reduce the Risk of Transmission of Human Immunodeficiency Virus (HIV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)." These draft guidances are intended to update existing guidances and to assist establishments making donor eligibility determinations in understanding the requirements for determining donor eligibility, including donor screening and testing, for donors of HCT/Ps. These draft guidances are also intended to provide establishments making donor eligibility determinations with recommendations to reduce the risk of transmission of specific communicable disease agents and diseases, specifically, hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV), by HCT/Ps.

🧬FDA Guidance on Heritable Genomic Alterations in Animals

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry #187B entitled "Heritable Intentional Genomic Alterations in Animals: The Approval Process." This guidance clarifies FDA's requirements and recommendations for developers of intentional genomic alterations (IGAs) in animals. The guidance is one of two companion documents. "Heritable Intentional Genomic Alterations in Animals: The Approval Process" describes how the FDA approval process applies to heritable IGAs in animals. The companion final guidance, GFI #187A entitled "Heritable Intentional Genomic Alterations in Animals: Risk-Based Approach," describes FDA's risk-based regulatory approach to the oversight of heritable IGAs in animals.

🥣FDA Sets New Lead Action Levels for Baby Food Compliance

The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for industry entitled "Action Levels for Lead in Processed Food Intended for Babies and Young Children." The guidance establishes action levels for lead in certain processed foods intended for babies and young children less than 2 years old. The guidance is intended to set achievable action levels that will help further reduce lead in the food supply.